30 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4
FDA 510(k)
FDA Class 2
·Radiology
HAMILTON-T1
FDA UDI
Hamilton Medical AG·07630002806091·
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304250741·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694040716·PrimaLIF LLIF 9mm x 22mm Lordotic Trial
Mui Scientific
FDA UDI
H & A Mui Enterprises Inc·10678467505313·CUSTOMIZED SINGLE-USE ANTRODUODENAL 16Ch CATHETER
Mui Scientific
FDA UDI
H & A Mui Enterprises Inc·10678467004397·Customized Single Use 16CH HRAM Catheter
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122254·KWire .062x4" (1.6x100mm)
ARSENAL PETITE LAPIDUS PLATE, R
FDA Adverse Event
Injury
·TRILLIANT SURGICAL·Product code HRS·April 3, 2020
PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACRYLIC HERBST APPLIANCE
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 8, 2024
BREATHING CIRCUIT SET
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code BZO·May 27, 2026
BREATHING CIRCUIT SET
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code BZO·May 28, 2026
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·October 10, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
UNICEL DXC 600I SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JGS·June 17, 2011
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·September 19, 2018
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·March 8, 2021
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·January 11, 2018
GRACE MEDICAL, INC. NOTCHED TITANIUM BUCKET HANDLE
FDA Adverse Event
Injury
·GRACE MEDICAL, INC.·Product code ETB·July 3, 2019